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    Summary
    EudraCT Number:2007-003462-18
    Sponsor's Protocol Code Number:AP23573-07-302
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-01-17
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedFrance - ANSM
    A.2EudraCT number2007-003462-18
    A.3Full title of the trial
    A Pivotal Trial to Determine the Efficacy and Safety of AP23573 when Administered as Maintenance Therapy to Patients with Metastatic Soft-Tissue or Bone Sarcomas
    A.4.1Sponsor's protocol code numberAP23573-07-302
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorARIAD Pharmaceuticals, Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/05/321 and EU/3/05/312
    D.3 Description of the IMP
    D.3.1Product nameDeforolimus
    D.3.2Product code AP23573
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNdeforolimus
    D.3.9.1CAS number 572924-54-0
    D.3.9.2Current sponsor codeAP23573
    D.3.9.3Other descriptive nameMK-8669
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients who have benefited from cytotoxic chemotherapy. Patients will have either metastatic soft-tissue or bone sarcoma, with histological category (soft-tissue or bone) as one of the baseline stratification factors. Impotantly, in this trial, bone sarcoma patients must have visceral metastatic disease (e.g., metastatic to lung or liver), or have achieved response of visceral metasrasis.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10006008
    E.1.2Term Bone sarcoma NOS
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level HLGT
    E.1.2Classification code 10041299
    E.1.2Term Soft tissue sarcomas
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare progression-free survival (PFS) of patients who have achieved complete response, partial response or stable disease following first, second or third line chemotherapy when treated with AP23573 versus placebo.
    E.2.2Secondary objectives of the trial
    1. To compare the overall survival (OS) of patients when treated with AP23573 versus placebo.
    2. To compare the best target lesion response of patients receiving AP23573 versus placebo.
    3. To assess changes in cancer-related symptoms in those patients treated with AP23573 compared to those treated with placebo.
    4. To determine the safety and tolerability of AP23573.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    A Pivotal Trial to Determine the Efficacy and Safety of AP23573 when Administered as Maintenance Therapy to Patients with Metastatic Soft-Tissue or Bone Sarcomas

    Protocol number: AP23573-07-302

    Amendment 1: V1.1 25 July 2007

    A sub-study of the above mentioned protocol is intended to study potential biomarkers (in consenting patients) that are related to clinical outcome or to patient response to AP23573. Details relating to this biomarker study are provided in section 13.5.3 of the above mentioned protocol.
    E.3Principal inclusion criteria
    1. Documented histologic diagnosis of soft-tissue or bone sarcoma that has metastasized, with the exception of certain histopathologic subtypes of sarcomas recognized by experts to derive no benefit from conventional chemotherapies or with distinctly different natural histories. See Attachment G for a list of excluded sarcoma sub-types.
    2. Ongoing complete response, partial response or stable disease as defined by RECIST guidelines after a minimum of 4 cycles (and maximum of 12 months) of any one of 1st, 2nd or 3rd line of prior cytotoxic chemotherapy for metastatic disease.
    3. Disease status (SD or better response) confirmed by a central review of the most recent 2 consecutive radiological evaluations (e.g., CT or MRI scans) obtained a minimum of 6 and a maximum of 10 weeks apart.
    4. Patients with partial response or stable disease at study entry must have least one measurable or evaluable lesion as defined by RECIST guidelines (see protocol Attachment D)
    5. Patients with metastatic bone sarcoma must have at least one measurable visceral lesion or have achieved a complete response of visceral metastasis.
    6. ECOG performance status of 0 or 1 (see protocol Attachment A)
    7. Male or female patients ≥ 13 years of age (patients 13-17 years of age must weigh at least 100lbs. (45.4 kg)). In regions where applicable local law prohibits enrollment of patients <18 years of age, only patients ≥18 years of age will be eligible.
    8. Patients must have normal organ and marrow function as defined below:
    • leukocytes ≥ 3,000/μL
    • absolute neutrophil count ≥ 1,500/μL
    • platelets ≥ 100,000/μL
    • total bilirubin below institutional upper limit of normal (unless patient has Gilbert’s disease in which case ≤1.5 x ULN)
    • AST(SGOT)/ALT(SGPT) ≤ 2.5 X institutional upper limit of normal (or ≤ 5 x ULN if liver metastases are present)
    • creatinine ≤1.5 X ULN for the institution (or calculated creatinine clearance ≥ 50 mL/min/1.73 m2)
    9. Serum cholesterol ≤ 350 mg/dL and triglycerides ≤ 400 mg/dL
    10. Male and female patients who are not surgically sterile or postmenopausal must agree to use reliable methods of birth control from time of screening until 30 days after the last dose of the study drug
    11. Able to understand and willing to sign a written informed consent document
    12. Completed 1st, 2nd or 3rd line chemotherapy and have received last dose ≥ 3 weeks prior to randomization
    13. Randomization and treatment to begin ≤ 8 weeks following previous treatment
    E.4Principal exclusion criteria
    1. Women who are pregnant or lactating
    2. Presence of known or active brain or CNS metastases
    3. Prior therapy with rapamycin or rapamycin analogs, including AP23573
    4. Ongoing toxicity associated with prior anticancer therapy ≥ Grade 2 (excluding alopecia) according NCI common terminology criteria
    5. Another primary malignancy within the past three years (except for non-melanoma skin cancer and cervical carcinoma in situ)
    6. Known Grade 3 or 4 hypersensitivity to macrolide antibiotics (e.g., clarithromycin, erythromycin, azithromycin)
    7. Concomitant treatment with medications that induce or inhibit CYP3A. Patients should be off these medications ≥ 2 weeks prior to the first dose of AP23573
    8. Significant uncontrolled cardiovascular disease
    9. Active infection requiring systemic therapy
    10. Known HIV infection
    11. Concurrent treatment with immunosuppressive agents other than prescribed corticosteroids at stable doses for ≥ 2 weeks prior to first planned dose of study drug
    12. Inadequate recovery from any prior surgical procedure or having undergone any major surgical procedure within 2 weeks prior to the first dose of study drug (with the exception of minor procedures, e.g., central venous access port placement)
    13. Presence of any life-threatening illness or organ system dysfunction which, in the option of the Investigator, would either compromise the patient’s safety or interfere with evaluating the safety of the study drug
    E.5 End points
    E.5.1Primary end point(s)
    Progression-free survival, defined as the time from the date of randomization to the date of documented progressive disease, recurrence or death (whichever occurs first)
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA58
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    Six months after all patients have completed all study visits or have otherwise completed the study. A different definition was used because the Sponsor intends to allow additional time for monitoring and data clarifications.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months6
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state56
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 255
    F.4.2.2In the whole clinical trial 705
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2008-04-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-01-17
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-09-18
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